Method Development Chemist - Analytical Sciences

Role Overview:

You will have a dual-mandate role at Hubot India Private Limited, where you will support U.S. lab operations remotely while also leading the establishment of Hubot India's analytical and testing laboratory in Mumbai. This role offers a unique opportunity to be involved in method development, transfer, verification, and building a lab from the ground up.

Key Responsibilities:

• Independently perform method development, transfer, verification, and validation for chromatographic and spectrophotometric techniques such as HPLC, UPLC, GC, TOC, UV/Vis, FTIR, and titration.
• Lead cleaning validation method development, including swab and rinse sample testing, MACO/limit calculations, verification, and protocol and report authoring.
• Review laboratory testing data for accuracy, GLP compliance, and specification conformance.
• Assist in laboratory investigations, deviations, and CAPA preparation and execution.
• Lead the planning, setup, qualification, and operationalization of the analytical laboratory in Mumbai, including instrument procurement, SOP development, and personnel hiring.
• Oversee instrument qualification and method transfer from the U.S. to India lab.
• Establish regulatory readiness for customer audits and Indian regulatory requirements.

Qualification Required:

• Demonstrated expertise in HPLC, UPLC, GC, and TOC, including method development, validation, troubleshooting, and data interpretation.
• 8 years of hands-on analytical chemistry experience in a GMP/GLP-regulated environment.
• Experience in method development, transfer, and validation per ICH Q2(R1) and USP standards.
• Proficiency in Cleaning Validation, method development, sample testing, and full protocol and report authoring.
• Familiarity with LIMS platforms, electronic data review systems, and chromatography data systems.
• Previous experience in lab setup and instrument qualification is preferred.
• Strong communication skills and the ability to work collaboratively with cross-functional teams.

About the Company:

Hubot India Private Limited is a subsidiary of Hubot, Inc., serving Fortune 500 pharmaceutical and personal care brands. The company is focused on building a world-class analytical function operating in direct partnership with U.S. Quality and Technical teams. This role offers a clear career path with opportunities for growth and advancement.

(Note: Any additional details about the company were not provided in the job description.) Role Overview:

You will have a dual-mandate role at Hubot India Private Limited, where you will support U.S. lab operations remotely while also leading the establishment of Hubot India's analytical and testing laboratory in Mumbai. This role offers a unique opportunity to be involved in method development, transfer, verification, and building a lab from the ground up.

Key Responsibilities:

• Independently perform method development, transfer, verification, and validation for chromatographic and spectrophotometric techniques such as HPLC, UPLC, GC, TOC, UV/Vis, FTIR, and titration.
• Lead cleaning validation method development, including swab and rinse sample testing, MACO/limit calculations, verification, and protocol and report authoring.
• Review laboratory testing data for accuracy, GLP compliance, and specification conformance.
• Assist in laboratory investigations, deviations, and CAPA preparation and execution.
• Lead the planning, setup, qualification, and operationalization of the analytical laboratory in Mumbai, including instrument procurement, SOP development, and personnel hiring.
• Oversee instrument qualification and method transfer from the U.S. to India lab.
• Establish regulatory readiness for customer audits and Indian regulatory requirements.

Qualification Required:

• Demonstrated expertise in HPLC, UPLC, GC, and TOC, including method development, validation, troubleshooting, and data interpretation.
• 8 years of hands-on analytical chemistry experience in a GMP/GLP-regulated environment.
• Experience in method development, transfer, and validation per ICH Q2(R1) and USP standards.
• Proficiency in Cleaning Validation, method development, sample testing, and full protocol and report authoring.
• Familiarity with LIMS platforms, electronic data review systems, and chromatography data systems.
• Previous experience in lab setup and instrument qualification is preferred.
• Strong communication skills and the ability to work collaboratively with cross-functional teams.

About the Company:

Hubot India Private Limited is a subsidiary of Hubot, Inc., serving Fortune 500 pharmaceutical and personal care brands. The company is focused on building a world-class analytical function operating in direct partnership with U.S. Quality and Technical teams. This role offers a clear career path with opportunities for growth and advancement.

(Note: Any additional details about the company were not provided in the job description.)